Impact of an integrated care program on glycemic control and cardiovascular risk factors in patients with type 2 diabetes in Saudi Arabia: an ...
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Tourkmani et al. BMC Family Practice (2018) 19:1 DOI 10.1186/s12875-017-0677-2 RESEARCH ARTICLE Open Access Impact of an integrated care program on glycemic control and cardiovascular risk factors in patients with type 2 diabetes in Saudi Arabia: an interventional parallel- group controlled study Ayla M. Tourkmani, Osama Abdelhay, Hesham I. Alkhashan, Aboud F. Alaboud, Ahmed Bakhit, Tarek Elsaid, Ahmed Alawad, Aljohara Alobaikan, Hala Alqahtani, Abdulaziz Alqahtani, Adel Mishriky, Abdulaziz bin Rsheed and Turki J. Alharbi* Abstract Background: Long intervals between patient visits and limited time with patients can result in clinical inertia and suboptimal achievement of treatment goals. These obstacles can be improved with a multidisciplinary care program. The present study aimed to assess the impact of such a program on glycemic control and cardiovascular risk factors. Methods: In a randomized, parallel-group trial, we assigned 263 patients with poorly controlled type 2 diabetes mellitus (T2DM) to either a control group, standard care program, or a multidisciplinary care program involving a senior family physician, clinical pharmacy specialist, dietician, diabetic educator, health educator, and social worker. The participants were followed for a median of 10 months, between September 2013 and September 2014. Glycated hemoglobin (HbA1c), fasting blood glucose (FBG), lipid profiles, and blood pressure (BP) were measured. The assignment was blinded for the assessors of the study outcomes. The study registry number is. Results: In the intervention group, there were statistically significant (p < 0.05) post-intervention (relative) reductions in the levels of HbA1c (−27.1%, 95% CI = −28.9%, −25.3%), FBG (−17.10%, 95% CI = −23.3%, −10.9%), total cholesterol (−9.93%, 95% CI = −12.7%, −7.9%), LDL cholesterol (−11.4%, 95% CI = −19.4%, −3.5%), systolic BP (−1.5%, 95% CI = −2.9%, −0.03%), and diastolic BP (−3.4%, 95% CI = −5.2%, −1.7%). There was a significant decrease in the number of patients with a HbA1c ≥10 (86 mmol/mol) from 167 patients at enrollment to 11 patients after intervention (p < 0.001). However, the intervention group experienced a statistically significant increase in body weight (3.7%, 95% CI = 2.9%, 4.5%). In the control group, no statistically significant changes were noticed in different outcomes with the exception of total cholesterol (−4.10%, p = 0.07). In the linear regression model, the intervention and the total number of clinic visits predicted HbA1c improvement. Conclusions: Implementation of a patient-specific integrated care program involving a multidisciplinary team approach, frequent clinic visits, and intensified insulin treatment was associated with marked improvement in glycemic control and cardiovascular risk factors of poorly controlled T2DM patients in a safe and reproducible manner. Trial registration: ISRCTN Identifier: ISRCTN83437562 September 19, 2016 Retrospectively registered. Keywords: Type 2 diabetes, Cardiovascular risk, Glycemic control, Multidisciplinary care * Correspondence: turkifcm@yahoo.com Family and Community Medicine Department, Prince Sultan Military Medical City, P.O. Box 7897, Riyadh 11159, Saudi Arabia © The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Tourkmani et al. BMC Family Practice (2018) 19:1 Page 2 of 10 Background Center is staffed by senior family physicians who are Saudi Arabia has one of the highest rates of diabetes in board certified and/or specialized in diabetes care, a the world [1]. Local population studies estimate the board certified clinical pharmacist, dieticians, diabetic prevalence of diabetes at approximately 24% among educators, health educators, and social workers. The Saudi adults [2]. This is approximately three times the daily clinics are run by six physicians serving approxi- world average [1]. A recent epidemiologic forecast study mately 120 patients daily. that incorporated the high obesity and smoking preva- lence trends among Saudi adults estimated type 2 dia- Design betes mellitus (T2DM) at 44% in 2022 [3]. In addition to A randomized, controlled interventional study was con- the associated increased risk of morbidity and mortality, ducted between September 2013 and September 2014. T2DM among Saudis has led to a surge in healthcare Enrollment data were assessed by reviewing the patient utilization and allocated costs [4]. Diabetes is known to charts for at least two visits before joining the study. increase the risk of vascular diseases such as heart dis- Outcome data were assessed by prospectively following eases and stroke markedly [5]. This can be averted, or at patients for at least two visits after joining the study (for least delayed, by intensive glycemic control [6, 7], along a maximum of 9 months). Controls were recruited from with the control of associated risk factors such as hyper- the same center using the same eligibility criteria. All tension and dyslipidemia [7–9]. However, the compli- required ethical approvals from the local ethical commit- ance with these preventive measures by patients with tee were obtained before data collection. T2DM is inadequate [10, 11]. Primary care physicians manage most patients with Population and eligibility T2DM. However, long intervals between patient visits The study sample was recruited from adult patients, and limited time with patients can result in clinical iner- 18 years or older, with T2DM who received their dia- tia and, consequently, suboptimal achievement of treat- betic care at the Chronic Diseases Center of WHC. ment goals [12, 13]. Several strategies have been Patients who had at least two clinic visits before joining described to overcome barriers to efficient diabetes man- the study and were able to provide informed consent agement at primary care settings, including a multidis- were checked for eligibility for enrollment. Patients who ciplinary team approach [12, 14]. The implementation of received care from both diabetes clinics at the endocrin- such an approach was successful in improving diabetes ology department and primary care clinics were ex- care in primary care patients [15]. We have reported a cluded to avoid double care and to assure a standardized successful integrated care program for improving dia- level of management. The eligibility criteria included betes management in Saudi Arabia [16]. However, the one or more of the following: (1) poor glycemic control small sample size and the lack of control limited the in- (HbA1c >10 [86 mmol/mol] or persistent elevation of ferences from the study findings. The aim of the current HbA1c >8 [64 mmol/mol] for 1 year or more); (2) failure study was to evaluate the impact of a multidisciplinary to respond to therapeutic insulin dose of >2 units/kg or diabetic care program on glycated hemoglobin (HbA1c) 200 units irrespective of weight; (3) inadequate adher- and cardiovascular risk factors among patients with ence to insulin; (4) uncontrolled hypertension or hyper- poorly controlled T2DM in a primary care setting, using lipidemia with maximum possible combination of a controlled interventional design. The study assessed medications; (5) comorbidity such as cardiovascular, changes in HbA1c, fasting blood glucose (FBG), total renal, or hepatic disease; and (6) inadequate continuity cholesterol, triglycerides, HDL cholesterol, LDL choles- of care (such as recurrent missed appointments for insu- terol, systolic and diastolic blood pressure (BP), body lin titration). The eligible patients were consecutively weight, number of visits, and record of concomitant assigned to either the intervention or control groups medications and the frequency of adjustment. using a computerized random number generator. The 289 patients were assigned unique study numbers ran- Methods ging from 1 to 289. The number assigned was consistent Setting with the recruitment date (i.e., the first patient recruited The study was conducted in Al-Wazarat Chronic was assigned the number 1 and the last patient recruited Diseases Center, a division of the Al-Wazarat Health was assigned the number 289). The clinical pharmacist Care (WHC) Family Medicine Center in Riyadh, Saudi who acted as the case manager conducted assigned Arabia. The Chronic Diseases Center consists of 12 spe- study numbers. The biostatistician generated a random cialized clinics, primarily for patients with T2DM, hyper- sequence of 72 numbers out of 289 using a computer tension, dyslipidemia, and bronchial asthma, in addition program without knowing the order of the patients. The to a procedures room and support services such as phar- case manager assigned the patients’ numbers who macy, laboratory, and radiology. The Chronic Diseases matched those on the random sequence to the control
Tourkmani et al. BMC Family Practice (2018) 19:1 Page 3 of 10 group. The recruitment and randomization processes of and triglycerides), BP (systolic and diastolic), and body the patients are illustrated in Fig. 1. weight during the study relative to baseline were the outcomes measured. Sample size Considering the results of the pilot study, we proposed Intervention that an integrated care program can reduce HbA1c by 3 The integrated care program is a multidisciplinary pro- points and FBG by 3 mmol/L. To detect a 2-point differ- gram used for the care of patients in the intervention ence in HbA1c (3.0 versus 1.0 with a standard deviation group. Patients were referred from any discipline work- [SD] of 2.7) between the intervention and control groups ing in the Chronic Diseases Center when they fulfilled with 80% power and 95% confidence, 80 patients were the eligibility criteria for the integrated care program to required (60 in the intervention and 20 in the control the case manager. The program team included a senior group, assuming a ratio of 3:1). Similarly, to detect a dif- family physician, clinical pharmacy specialist who acted ference of 2 mmol/L in FBG (3.0 versus 1.0 with a SD of as a case manager, dietician, diabetic educator, health 5.0) between the intervention and control groups with educator, and social worker. The program team met 80% power and 95% confidence, 264 patients were re- once or twice weekly to review the eligibility of referred quired (198 in the intervention and 66 in the control patients and to assess and decide on the care plans for group, assuming a ratio of 3:1). Therefore, the larger those who had already been enrolled. The care provided sample size was adopted. The researchers opted to select was the standard care per the guidelines of the American a smaller size for the control group compared with the Diabetes Association (ADA) [17], but intensified with intervention (1 to 3) to maximize the number of patients consideration for individual clinical and social factors. gaining potential benefits from the intervention. The case manager was responsible for arranging re- quired appointments with other specialties as per the Outcome care plan, as well as evaluating the compliance and ad- The absolute and relative changes in the levels of verse effects of the new plan, through at least weekly ap- HbA1c, FBG, blood lipids (total, LDL, HDL cholesterol, pointments in the first 3 months. Enrolled patients had Fig. 1 Flow diagram of the progress in a randomized controlled trial
Tourkmani et al. BMC Family Practice (2018) 19:1 Page 4 of 10 to be seen at least once by all members of the program of change in the study outcomes was defined as the team during the period of enrollment, with the excep- amount of change during the study relative to baseline tion of the social worker who was seen on an as-needed at enrollment. The change in the levels of the study out- basis. Strategies to improve the care were patient-based comes was examined using a paired t-test. The correla- and included (but not limited to) providing more clinic tions between the change in HbA1c and the patient’s age visits, frequent monitoring of outcomes, improving and clinical and management factors were examined multidisciplinary communication and coordination, pro- using Spearman’s correlation. Independent predictors of viding additional diabetic education and dietetic advice, HbA1c change were evaluated using a multivariate linear promoting self-management, providing a booklet for regression model. All p-values were two-tailed. P-values home blood glucose monitoring, adjusting doses accord-
Tourkmani et al. BMC Family Practice (2018) 19:1 Page 5 of 10 Table 1 Demographic and clinical data of the study groups at multiple daily doses (p < 0.001), and more total insulin enrollment daily dose per kg (1.3 ± 0.7 versus 0.6 ± 0.4, p < 0.001) Intervention Control p-valuea compared with the control group. They also had signifi- (N = 195) (N = 68) cantly higher total number of visits (11.9 ± 6.6 versus Age (years) 5.1 ± 4.8, p < 0.001), as well as visits to a case manager, < 50 47 (24.1%) 15 (22.1%) diabetes educator, and health educator compared with 50-59 68 (34.9%) 22 (32.4%) the control group. ≥ 60 80 (41.0%) 31 (45.6%) The enrollment and final levels, as well as the changes in the study outcomes, are shown in Table 2. In the Range 20-85 33-83 intervention group, there were significant decreases in Mean ± SDb 56.9 ± 12.0 57.7 ± 11.6 0.649 the percentage of change relative to baseline in the levels Sex of HbA1c (−27.08%, p < 0.001), FBG (−17.0%, p < 0.001), Male (92) 67 (34.4%) 25 (36.8%) 0.720 total cholesterol (−9.93%, p < 0.001), LDL cholesterol Female (171) 128 (65.6%) 43 (63.2%) (−11.44%, p = 0.005), systolic BP (−1.49.0%, p = 0.046), Comorbidities and diastolic BP (−3.410%, p < 0.001) but significant rela- tive increase in body weight (3.72%, p < 0.001). In the Numberb 2.3 ± 0.8 3.0 ± 1.0
Tourkmani et al. BMC Family Practice (2018) 19:1 Page 6 of 10 Table 2 Paired post-pre changes (as a percent of the baseline) in HbA1c, blood glucose and lipids, blood pressure and body weight among patients in the intervention and control groups Mean ± SD of difference of relative Lower confidence Upper confidence Paired df P-value* changes related to start of the study t-test Intervention HbA1c −27.08 ± 12.90 −25.26 −28.90 −29.31 194
Tourkmani et al. BMC Family Practice (2018) 19:1 Page 7 of 10 Fig. 3 a Comparison of different categories of HbA1c at enrollment and final stage of follow up. b Change in HbA1c category for both the intervention and control cohorts Table 3 Absolute difference at the end of the study between intervention and control group, showed statistically significant difference in HbA1c, FBG, Cholesterol, LDL and Body weight parameters with P value (
Tourkmani et al. BMC Family Practice (2018) 19:1 Page 8 of 10 Table 4 Correlation between the pre-post changes in HbA1c levels and certain patients’ personal and disease and service characteristics Spearman rank correlation Total Intervention Control HbA1c HbA1c HbA1c HbA1c HbA1c HbA1c (pre-post diff) (pre-post diff % of pre) (pre-post diff) (pre-post diff % of pre) (pre-post diff) (pre-post diff % of pre) HbA1c .992§ .984 § .997§ (pre-post diff % of pre) Age −0.03 −0.02 −0.03 −0.01 0.07 0.07 Duration of DM −0.11 −0.10 −0.11 −0.10 −0.54 −0.54 Insulin total .177§ .172§ 0.00 −0.01 −0.01 −0.02 dose/kg Number of: Comorbidities −.229§ −.232§ 0.03 0.03 −0.02 −0.01 Insulin types .423 § .427§ −0.04 −0.05 0.21 0.21 Oral drugs 0.08 0.07 0.02 0.00 −0.05 −0.03 All medications .409§ .408§ −0.02 −0.04 0.17 0.18 Number of visits to: Doctor −.184§ −.180§ −0.05 −0.05 0.11 0.11 Case manager .597 § .612§ .314§ .331§ −0.06 −0.07 Dietitian −.214§ −.215§ −0.08 −0.08 0.02 0.02 DM educator .172§ .183§ 0.06 0.08 0.19 0.20 Health educator .479§ .491§ 0.10 0.10 Total visits .552§ .569§ .303§ .321§ 0.11 0.11 DM diabetes mellitus (§) Statistically significant at p < 0.01 specialized diabetes centers were shown to have poor manager, may have improved insulin intensification that diabetes control, with the ADA standards of diabetic is not usually tackled by primary care physician [30, 31]. care not met [24–26]. Several challenges to proper dia- The integrated care program in the current study was betes management in primary care setting have been de- associated with a considerably better lipid profile and a scribed. These include insufficient patient education, slight reduction in BP. Similar findings have been reported inadequate patient adherence to medication, infrequent before with a considerable increase in the number of those clinic visits, lack of social support, lack of home blood with controlled total and LDL cholesterol and those with glucose monitoring, inadequate physician attitude and controlled BP after a multidisciplinary care [15, 19, 32– approach, and system barriers [27–29]. The integrated 34]. However, the percentage changes in BP and, to a care program described in this study was designed to lesser extent, blood lipids in the current study were less deal with all the above challenges. remarkable compared with glycemic control, probably in- The more frequent clinic visits were the only strategy dicating the need for more involvement by dietitians, es- to predict improved HbA1c levels independently in the pecially given that visits to dietitians were less frequent current study. It appeared that several other components compared with other team members and were not differ- of the integrated care program that were correlated in ent between the intervention and control groups. It should univariate analysis to improved HbA1c levels, such as also be mentioned that the modest increase in body appropriate insulin types and doses, are only working weight that was observed in the intervention group in this through multiple clinic visits. Additionally, the contribu- study and other studies may be related to increased insulin tion of clinical pharmacist, who worked as the case use among these patients [20]. Table 5 Best fitting multiple linear regression model for the improvement in the level of HbA1c after the intervention Unstandardized Coefficients Standardized t-test p-value 95% Confidence Interval for B Coefficients B Std. Error Lower Upper Constant 4.82 0.53 9.09
Tourkmani et al. BMC Family Practice (2018) 19:1 Page 9 of 10 Limitations and strengths Availability of data and materials The current study has the advantages of examining the The datasets used and/or analyzed during the current study available from the corresponding author on reasonable request. effects of a multidisciplinary, multifaceted integrated care program on multiple outcomes and detecting the Authors’ contributions predictors of improved glycemic control, using an ap- TA and AT are the guarantors of the data. Author Contributions: TA, AT, and OA researched the data and wrote the manuscript; AM, AAlqahtani, and propriate sample size and controlled design. Findings HAlqahtani researched the data and reviewed the manuscript; HAlkashan, showed the impact of diabetes care conducted at the pri- AB, TE, AAlawad, AAlobaikan, AbR and AFA reviewed the manuscript and mary care level was an appropriate model of care. contributed to the discussion; AM and OA researched the data, reviewed and edited the manuscript, and conducted the statistical analyses. All Nevertheless, we acknowledge some limitations, such authors read and approved the final manuscript. differences between the two groups at enrollment. How- ever, these differences were not in one direction, were Ethics approval and consent to participate The Prince Sultan Military Medical City ethical committee ethically approved less clinically meaningful, and probably had no effect on this study. The ethical approval number SA555 and the clinical trial is the study findings. For example, the patients in the con- registered under the number ISRCTN83437562. This study was conducted in trol group, who had slightly more comorbidities, had accordance to all Saudi regulations. The participants signed an informed consent for participation and publication. slightly better glycemic control. Moreover, the differ- ences in hypertension and dyslipidemia were not associ- Consent for publication ated with differences in BP or blood lipids. The lack of Not applicable. blindness for both patients and care providers may con- Competing interests tribute to bias in the results. We tried to minimize such The authors declare that they have no competing interests. effects by blinding the results to the outcomes assessors (i.e., labs workers and nurses). Additionally, further re- Publisher’s Note search encouraged to conduct to evaluate health eco- Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. nomic during implementation of integrated care program through multidisciplinary team approach. Received: 9 March 2017 Accepted: 11 December 2017 Conclusions References In conclusion, the implementation of a patient-tailored, 1. Whiting DR, Guariguata L, Weil C, Shaw J. IDF diabetes atlas: global estimates of the prevalence of diabetes for 2011 and 2030. Diabetes Res integrated care program involving a multidisciplinary Clin Pract. 2011;94(3):311–21. team approach, frequent clinic visits, and intensified in- 2. Al-Nozha MM, Al-Maatouq MA, Al-Mazrou YY, Al-Harthi SS, Arafah MR, Khalil sulin treatment in a primary care setting was associated MZ, et al. Diabetes mellitus in Saudi Arabia. Saudi Med J. 2004;25(11):1603–10. 3. 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